Non-invasive Assessment of Intracranial Pressure Using Ocular Sonography in Patients Undergoing Laparoscopic Sleeve Gastrectomy

Laparoscopic gastric sleeve gastrectomy is becoming an increasingly frequent procedure for patients with severe obesity and its related diseases, such as type 2 diabetes, hypertension, dyslipidemia, and sleep apnea.

Assessing the optic nerve sheath diameter (ONSD) with noninvasive ultrasonography has shown to be accurate in determining increased ICP as pressure changes in the subarachnoid space and the cerebrospinal fluid reflect variations in the optic nerve sheath (ONS).

The investigators hypothesized that if ICP during laparoscopy is different according to the position, ONSD would likewise be different. Thus, investigators will investigate the change of ONSD according to the positional change in laparoscopic sleeve gastrectomy surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Optic Nerve Sheath Diameter; Laparoscopic Sleeve Gastrectomy
• Intervention / Treatment: Diagnostic test: ultrasonographic measurement of the optic nerve sheath diameter

Detailed Description

Laparoscopic gastric sleeve gastrectomy is becoming an increasingly frequent procedure for patients with severe obesity and its related diseases, such as type 2 diabetes, hypertension, dyslipidemia, and sleep apnea.

The impacts of laparoscopy on the intracranial pressure (ICP) are well-documented and several studies have demonstrated that the induction of artificial pneumoperitoneum provokes a measurable increase in ICP. The mechanisms of increase of ICP during laparoscopy are suggested as follows: increase of intra-abdominal pressure, impairment of cerebrospinal fluid (CSF) absorption and impeded drainage of the lumbar venous plexus, increased pressure in the vascular compartment of sacral spaces, Trendelenburg position, and cerebral vasodilation due to hypercarbia.

Neurological comorbidities resulting in chronically elevated ICP-pseudotumor cerebri and idiopathic intracranial hypertension-may develop in morbidly obese individuals without discernable clinical manifestations.

Assessing the optic nerve sheath diameter (ONSD) with noninvasive ultrasonography has shown to be accurate in determining increased ICP as pressure changes in the subarachnoid space and the cerebrospinal fluid reflect variations in the optic nerve sheath (ONS) .

A study on ultrasonographic measurement of ONSD laparoscopic radical prostatectomy with steep Trendelenburg positioning revealed that ONSD increased approximately 12.5% and the increase of ICP corresponding to change of ONSD could be predicted. However, no study measured the changes of ONSD according to the positional change with reversed Trendelenburg position during laparoscopic sleeve gastrectomy. The investigators hypothesized that if ICP during laparoscopy is different according to the position, ONSD would likewise be different. Thus, investigators will investigate the change of ONSD according to the positional change in laparoscopic sleeve gastrectomy surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients older than 18 years old undergoing laparoscopic sleeve gastrectomy under general anesthesia.

Exclusion Criteria:

• pre-existing neurological (e.g. hydrocephalus, intracranial hemorrhage, Etc.) Or cerebrovascular disease, past medical history of ocular pathology or surgery and the use of ketamine and/or succinylcholine during anesthesia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: optic nerve sheath diameter by using ocular sonography	Diagnostic test: ultrasonographic measurement of the optic nerve sheath diameter; Assessing the optic nerve sheath diameter as an indicator of intracranial pressure during different positions and on specific time intervals in patients undergoing laparoscopic sleeve gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
optic nerve sheath diameter	will be measured In the supine position after induction of anesthesia, 3 min after the steep anti-Trendelenburg position (35° incline), 3 min after the steep anti-Trendelenburg position combined with pneumoperitoneum, every 15 minutes and In the supine position after 3 min of de-sufflation of the pneumoperitoneum	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean blood pressure (MBP)	will be measured In the supine position after induction of anesthesia, 3 min after the steep anti-Trendelenburg position (35° incline), 3 min after the steep anti-Trendelenburg position combined with pneumoperitoneum, every 15 minutes and In the supine position after 3 min of de-sufflation of the pneumoperitoneum	3 months
Heart rate (HR)	will be measured In the supine position after induction of anesthesia, 3 min after the steep anti-Trendelenburg position (35° incline), 3 min after the steep anti-Trendelenburg position combined with pneumoperitoneum, every 15 minutes and In the supine position after 3 min of de-sufflation of the pneumoperitoneum	3 months
Airway peak pressure (Ppeak)	will be measured In the supine position after induction of anesthesia, 3 min after the steep anti-Trendelenburg position (35° incline), 3 min after the steep anti-Trendelenburg position combined with pneumoperitoneum, every 15 minutes and In the supine position after 3 min of de-sufflation of the pneumoperitoneum	3 months
ETCO2	will be measured In the supine position after induction of anesthesia, 3 min after the steep anti-Trendelenburg position (35° incline), 3 min after the steep anti-Trendelenburg position combined with pneumoperitoneum, every 15 minutes and In the supine position after 3 min of de-sufflation of the pneumoperitoneum	3 months

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1234 (Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No